FDA Table 3

Patient Screening and Enrollment, Trials A and B

Disposition                              A: Drug X    B: Placebo    C: Combination
——————————————————————————————————————————————————————————————————————————————————
Patients screened                           134           134            132      
Screening failures                       42 (31.3%)   32 (23.9%)      26 (19.7%)  
  Inclusion/exclusion criteria not met    6 (4.5%)     10 (7.5%)      10 (7.6%)   
  Patient noncompliance                  12 (9.0%)     2 (1.5%)        6 (4.5%)   
  Consent withdrawn                      13 (9.7%)     12 (9.0%)       5 (3.8%)   
  Other                                  11 (8.2%)     8 (6.0%)        5 (3.8%)   
Patients enrolled                        92 (68.7%)   102 (76.1%)    106 (80.3%)  
Patients randomized                      92 (68.7%)   102 (76.1%)    106 (80.3%)  
# Load Libraries & Data
library(dplyr)
library(cardinal)

adsl <- random.cdisc.data::cadsl

# Pre-Processing - Add all required screening variables are in df
set.seed(1)
adsl <- random.cdisc.data::cadsl
adsl$RANDDT[sample(seq_len(nrow(adsl)), 100)] <- NA
adsl <- adsl %>%
  mutate(
    ENRLDT = RANDDT,
    SCRNFL = "Y",
    SCRNFRS = factor(sample(
      c("Inclusion/exclusion criteria not met", "Patient noncompliance", "Consent withdrawn", "Other"),
      size = nrow(adsl), replace = TRUE
    ), levels = c("Inclusion/exclusion criteria not met", "Patient noncompliance", "Consent withdrawn", "Other")),
    SCRNFAILFL = ifelse(is.na(ENRLDT), "Y", "N")
  )
adsl$SCRNFRS[adsl$SCRNFL == "N" | !is.na(adsl$ENRLDT)] <- NA

# Output Table
make_table_03(df = adsl, scrnfl_var = "SCRNFL", scrnfailfl_var = "SCRNFAILFL", scrnfail_var = "SCRNFRS")

make_table_3()

Required variables:

  • adsl: USUBJID, ENRLDT, RANDDT, and the variables specified by arm_var, scrnfl_var, scrnfailfl_var, and scrnfail_var.
  • alt_counts_df (if specified): USUBJID, and the variable specified by arm_var.
Argument Description Default
adsl (data.frame) Dataset (typically ADSL) required to build table. No default
alt_counts_df (character) Alternative dataset used only to calculate column counts. NULL
show_colcounts (flag) Whether column counts should be printed. FALSE
arm_var (character) Arm variable used to split table into columns. "ARM"
scrnfl_var (character) Variable from df that indicates whether patients were screened. No default
scrnfailfl_var (character) Variable from df that indicates screening failure. No default
scrnfail_var (character) Variable from df that contains reasons for screening failure. No default
lbl_overall (character) If specified, an overall column will be added to the table with the given value as the column label. NULL
prune_0 (flag) Whether all-zero rows should be removed from the table. TRUE
annotations (named list of character) List of annotations to add to the table. Valid annotation types are title, subtitles, main_footer, and prov_footer. Each name-value pair should use the annotation type as name and the desired string as value. NULL

Source code for this function is available here.